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NOT YET RECRUITING
NCT06944795
NA

SWIR Otoscopy Study

Sponsor: Stanford University

View on ClinicalTrials.gov

Summary

The aim of this study is to provide preliminary data to support future studies to demonstrate that the short wave infrared (SWIR) otoscope is a better diagnostic tool than a white light otoscope for diagnosing middle ear infections (otitis media). Patients who are having a tympanostomy tube placement procedure will be participating in this study. Imaging will be performed with the white light otoscope and the SWIR otoscope to determine presence of absence of fluid. The SWIR otoscope will gather SWIR data and white light data simultaneously. As part of standard of care, patients who come in for this procedure have removal of middle ear fluid as part of their procedure, which will confirm presence or absence of fluid.

Official title: A Short Wave Infrared Otoscope for Objective Middle Ear Effusion Diagnosis

Key Details

Gender

All

Age Range

1 Year - 17 Years

Study Type

INTERVENTIONAL

Enrollment

100

Start Date

2025-05-01

Completion Date

2027-01

Last Updated

2025-04-30

Healthy Volunteers

No

Interventions

DEVICE

SWIR device

A Short Wave Infrared (SWIR) Otoscope will record images for both the SWIR and white light video otoscopes. These images of the middle ear will be recorded in AVI format.

Locations (2)

Stanford University

Palo Alto, California, United States

Children's National Hospital

Washington D.C., District of Columbia, United States